Irina Lavrynenko Email & Phone Number

Austin, Texas, United States

San Carlos, Ca, United States

Iovance Biotherapeutics is a late-stage oncology company that focuses on the development, manufacturing and commercialization of cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL). In my role, I was responsible for QA Operations and Quality Systems. - Performed QA Operation activities that include product disposition, review of the manufacturing batch records, labeling/packaging, associated test results to ensure timely release of the cell therapy products- Interacted with the Contract Manufacturing Operations (CMOs) in US and Europe on a daily basis to obtain the necessary lot/batch documentation, test results, deviations needed to ensure a timely release the clinical product - Implemented and enhanced Batch Record Review procedures and work instructions based on the best practices and compliance requirements- Responsible for collecting and analyzing data to support the quarterly Quality Management Review (QMR) Metrics program across the company- Acted as an Subject Matter Expert (SME) to support the Biologic License Application (BLA) - Supported and assisted Management with regulatory inspection readiness through mock inspections, internal and external audits

San Carlos, Ca

- Reviewed and approved Master Batch Record (MBR) for manufacturing, testing, packaging and associated deviations (DEVs)- Responsible for the timely release/reject clinical lots and issuance of the appropriate release certificates - Developed Standard Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements

Foster City, Ca

Gilead Sciences is a biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. In my role, I was responsible for the following:- Maintained monthly Quality Metrics Program to ensure high quality products and compliance with current Gilead policies and procedures, GMPs and GLPs- Worked directly with the Contract Manufacturing Operations (CMOs) and Gilead internal manufacturing sites to collect and analyze data for the Monthly Quality Review Meetings- Acted as a core team member for the FDA Quality Metrics program, developed master form template for the CMOs and internal sites to collect and analyze data for the FDA program

The Colony, Tx

Eclipse Aesthetics is a privately held medical device company that developed its own brand of proprietary products and solutions for physicians in the US and internationally. I was brought on board as a CAPA Consultant to assist with the following: - Managed Corrective Action Preventive Action (CAPA) program at the site- Conducted Root Cause Analysis (RCA) using the following techniques: Pareto Chart, Fishbone Diagram, Failure Mode and Effect Analysis (FMEA), 5 Whys - Implemented company-wide eQMS (ISOExpress) for External Audits

Irving, Tx

- Collected and analyzed data at the monthly Quality Management Review (QMR) Meetings - Conducted risk analysis for the various Quality documents: NCEs, DEVs, CAPAs, Customer Complaints, SCARs- Worked with product development group to develop risk management documents, including Process Failure Mode and Effect Analysis (FMEA) to comply with ISO 14971 (Risk Management), assisted in developing the process maps for the manufacturing processes - Responsible for timely completion of the Monthly Trending Investigation Reports (TIRs)- Worked closely with R&D and other functions on developing and approving Risk Management Files

Irving, Tx

- Responsible for the timely initiation, investigation, implementation, and monitoring of assigned quality reports (CAPAs, NCEs, DEVs, SCARs)- Ensured CAPAs/NCEs root cause investigations and actions are clearly documented and implemented to fulfill regulatory requirements- Led CAPA Review Board Meetings - Led CAPA Investigations team to ensure adequate identification, evaluation & investigation to root cause- Ensured CAPA documents are properly maintained followed a Good Documentation Practices (GDPs)- Collected and analyzed data for the Trend Investigation Reports (TIRs)

Austin, Texas Area

- Performed daily office administrative tasks, client communication- Responsible for updating and maintaining clients financial portfolios - Processed investment related documents insuring compliance - Created marketing materials and gained its approval as well as distributed to the potential clients - Managed 2 college interns

Master Of Science (M.S.), Mechanical Engineering, 3.8

Bachelor Of Science (B.S.), Mechanical Engineering, 3.8